Evaluation of the efficacy of 10% gabapentin cream compared to base cream without Gabapentin in the treatment of pruritic lesions in patients with Epidermolysis bullosa.
Design
A non-randomized, double-blind; placebo-controlled clinical trial with blinded outcome assessment, 19 patients; convenient sampling.
Settings and conduct
A total of 19 patients with various forms of epidermolysis bullosa referred to the Faghihi Hospital will be included( Available/ convenient Sampling). The dermatologist first identifies two pruritic areas in each patient (A and B), each less than 3% of BSA, and then measures the size and erythema of each area. The lesions will be photographed and the Leuven-Itch-scale questionnaire is completed by the patients. Patients will receive 10% gabapentin cream on one side and base cream on the other (patients and dermatologists are unaware of the type of treatment on each side). Two similar containers are designed with labels A or B, and patients apply them 3 times a day for 6 weeks. Patients then return to the dermatology clinic at the end of week 6, and the rate of erythema, area size, and leuven-Itch-scale and imaging on each side are performed by a dermatologist.
Participants/Inclusion and exclusion criteria
Patients older than 6 years; different forms of epidermolysis bullosa (histologically confirmed); unresponsive to conventional antipruritic treatment, no pregnancy or lactating; no underlying systemic disease or disorders that can make them prone to itching, regardless of skin disease
Intervention groups
Two pruritic lesions are identified in each patient, then one of the lesions is treated with Gabapentin 10% cream (Prepared and formulated in the Dr. Rastegar pharmacy in Shiraz) and another lesion with a gabapentin-free base cream three times a day for 6 weeks.
Main outcome variables
Erythema, lesion size and leuven-itch-scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210822052258N1
Registration date:2021-09-15, 1400/06/24
Registration timing:prospective
Last update:2021-09-15, 1400/06/24
Update count:0
Registration date
2021-09-15, 1400/06/24
Registrant information
Name
Samira Vahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3638 1455
Email address
svhd7988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of topical Gabapentin for the treatment of pruritus in patients with Epidermolysis bullosa, Faghihi hospital, 2021
Public title
Evaluation of the efficacy of topical Gabapentin for the treatment of pruritus in patients with Epidermolysis bullosa
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age equal or more than 6 years;
Histologically confirmed any three major forms of epidermolysis bullosa (EB simplex (EBS), junctional EB (JEB), and dystrophic EB (DEB))
complain of persistent pruritic lesions unresponsive to the standard treatment
Exclusion criteria:
Use of oral gabapentin
Pregnancy or lactation
Concomitant kidney, liver, blood, thyroid, and psychiatric diseases or any other systemic disease that may cause pruritus
Age
From 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
19
More than 1 sample in each individual
Number of samples in each individual:
2
Two pruritic areas of skin are selected in each patient, one for medication and the other for placebo
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In each patient, two pruritic areas are defined for the use of medication or a placebo. The type of intervention in each lesion remains unclear to both, the patients and the researcher until the end of the study. Products are delivered within completely similar 50 gr containers. Containers are identified with adhesive labels (A or B) so the subjects and investigators are not aware of the kind of treatment in each lesion (double-blind design).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Local Ethics Committee, Shiraz University of Medical Sciences, Setad Squ., Zand Blvd., Shiraz.
City
Shiraz
Province
Fars
Postal code
7176913861
Approval date
2021-07-14, 1400/04/23
Ethics committee reference number
IR.SUMS.MED.REC.1400.210
Health conditions studied
1
Description of health condition studied
Epidermolysis bullosa
ICD-10 code
Q81
ICD-10 code description
Epidermolysis bullosa
Primary outcomes
1
Description
itching
Timepoint
Baseline and at the end of treatment (end of 6th week)
Method of measurement
Leuven_itch_scale
2
Description
Pruritic area size
Timepoint
Baseline and at the end of treatment (end of 6th week)
Method of measurement
(Length × width) ÷ 2
3
Description
Erythema
Timepoint
Baseline and at the end of treatment (end of 6th week)
Method of measurement
Examination: absent (0), mild (pink-1), moderate (pink to red-2), severe (red-3)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group receives topical Gabapentine 10%(plus 10%Glycerine in base of cold cream)formulized and prepared in Dr.Rastegar pharmacy on the assigned side 3 times daily for 6 weeks .
Category
Treatment - Drugs
2
Description
Control group: Control group uses base cream(۱۰% glycerin in cold cream) on the assigned side 3times daily for 6 weeks.